Transcultural Adaptation and Validation to Spanish of the OSPRO Questionnaires

Musculoskeletal Pain Clinical Trial

— SpanishOSPRO  

Official title:

Transcultural Adaptation and Validation to Spanish of the Optimal Screening for Prediction of Referral and Outcome (OSPRO) Questionnaires for Review-Of-Systems (OSPRO-ROS) and Yellow-Flags (OSPRO-YF) in Subjects With Musculoskeletal Pain.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869695
• Other study ID #: 102999
• Status: Recruiting
• Start date: November 30, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: University of Valencia
• Contact: MELÀNIA MASÓ NÚÑEZ
• Phone: +34935893727
• Email: melania.maso[@]eug.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Clinical guidelines for managing musculoskeletal pain recommend first, assessing and identifying any signs of severe physical conditions (i.e."red flags") and then, asessing the psychosocial prognostic factors of poor outcomes (i.e."yellow flags"). The Optimal Sreening for Prediction of Referral and Outcome (OSPRO) cohort studies were designed to develop and validate standard assessment tools for Review Of Systems (OSPRO-ROS) and Yellow Flags (OSPRO-YF).

Description:

The objectives of this study were to translate and cross-cultural adapt OSPRO-ROS and OSPRO-YF questionnaires to Spanish and to investigate their psychometric properties for their use in subjects with musculoskeletal pain.To accomplish the objectives proposed, this study was developed in two phases:Phase I: Cross-cultural adaptation process.Phase II: Psychometric properties evaluation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

OSPRO-ROS:

1. Were coming to the emergency department on their first visit.

2. With acute musculoskeletal pain.

3. Were able to read and comprehed Spanish language.

OSPRO-YF:

1. Were seeking outpatient physical therapy treatment.

2. With chronic musculoskeletal pain involving the cervical spine, lumbar spine, shoulder or knee.

3. Were able to read and comprehend Spanish language.

Exclusion Criteria:

1. Widespread chronic pain syndrome (e.g. fibromyalgia or irritable bowel syndrome).

2. Neuropathic pain syndrome (e.g. complex regional pain syndrome or diabetic neuropathy).

3. Psychiatric history (currently in care of mental health care provider or taking > 2 precription psychiatric medications)

4. Cancer (currently receiving treatment for active cancer)

5. Neurological disorder (e.g. stroke, spinal cord injury, or traumatic brain injury).

Related Conditions & MeSH terms

• Musculoskeletal Pain

Intervention

Other:
• OSPRO-ROS Questionnaire
Completion of questionnaires
• OSPRO-YF Questionnaire
Completion of questionnaires

Locations

Country	Name	City	State
Spain	Hospital Asepeyo Sant Cugat	Sant Cugat Del Vallès	Barcelona
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
University of Valencia	Consorci Sanitari de Terrassa, Escoles Universitaries Gimbernat, Hospital ASEPEYO Sant Cugat, University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Reported Outcome Measure (PROM) development: Translation and Cross Cultural Adaptation to the Spanish population of the Optimal Screening for Prediction of Referral and Outcome (OSPRO) questionnaires.	Two native Spanish speakers, health experienced in musculoskeletal pain and knowledge of English, translated into Spanish the Optimal Screening for Prediction of Referral and Outcome-Review of Systems (OSPRO-ROS) questionnaire original (English) and the Optimal Screening for Prediction of Referral and Outcome Yellow-Flags (OSPRO-YF) original questionnaire (English).; Two native English speakers, knowledge of Spanish, reverse-translate the text to Spanish.; 25 participants with musculoskeletal pain completed the Optimal Screening for Prediction of Referral and Outcome (OSPRO) questionnaires.; This outcome will be evaluated according the Consensus-based Standards for the selections of health Measurement Instruments (COSMIN) Risk of Bias checklist for PROMs, using their scoring manual: very good/adequate/doubtful/inadequate/NA for each standar.	from September 2018 to July 2021
Secondary	OSPRO questionnaires Psychometric property Validation	The validity and reliability of the Spanish version translated from the questionnaires Optimal Screening for Prediction of Referral and Outcome (OSPRO) will be assessed.; This outcome will be evaluated according the Consensus-based Standards for the selections of health Measurement Instruments (COSMIN) Risk of Bias checklist for PROMs, using their scoring manual: very good/adequate/doubtful/inadequate/NA for each standar.	from January to June 2024